Leksell Non-XY frame Mechanical Set KIT 700-020832-00

GUDID 27290114064099

ALPHA OMEGA ENGINEERING CO. LTD.

Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode Depth electrode

• Primary Device ID: 27290114064099
• NIH Device Record Key: a7e7ccd0-a42e-474e-90d1-6bd6e6db20c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Non-XY frame Mechanical Set KIT
• Version Model Number: Long Bengun
• Catalog Number: 700-020832-00
• Company DUNS: 531856466
• Company Name: ALPHA OMEGA ENGINEERING CO. LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	27290114064099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051830

FDA Product Code

• GZL: Electrode, Depth

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

[27290114064099]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-22
• Device Publish Date: 2023-09-14

On-Brand Devices [Leksell Non-XY frame Mechanical Set KIT]

• 27290114061111: 2
• 27290114064099: Long Bengun